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The effect of fish oil on the immune system and red blood cell function of patients around surgery.

Conditions
Patients undergoing colon surgery for malignancy.
MedDRA version: 17.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10009950Term: Colon cancer Duke's DSystem Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10009946Term: Colon cancer Duke's ASystem Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10009947Term: Colon cancer Duke's B1System Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10009948Term: Colon cancer Duke's B2System Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10009949Term: Colon cancer Duke's CSystem Organ Class: 100000004864
Therapeutic area: Body processes [G] - Immune system processes [G12]
Registration Number
EUCTR2013-003664-32-NL
Lead Sponsor
Medical Center Alkmaar
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

•Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
•Age between 60 and 80 years
•BMI between 20 kg/m2 and below 30 kg/m2
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

•Participation in or having participated in another clinical trial within the previous 3 months
•Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
•Bleeding disorders, determined by medical history and laboratory tests of clotting indices
•Metastatic disease
•Recent cardiac or cerebral infarction within the last 6 months
•Current history of inflammatory or infectious disease
•The use of anti-inflammatory drugs
•The use of thyroid medication
•The use of fish oil products or fish consumption more than 2 times a week
•Contra-indications for the use of Omegaven-Fresenius

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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